Various treatment techniques require the implantation of electrodes in, on, or around a portion of the gastrointestinal (GI) tract. Such electrodes are often implanted subserosally or submucosally.
U.S. Pat. No. 6,826,428 to Chen et al., which is incorporated herein by reference, describes a method for regulating gastrointestinal (GI) action in a subject using a stimulatory electrode and a sensor to provide retrograde feedback control of electrical stimulation to the GI tract. The '428 patent also describes a method which uses a needle to insert a device, such as an electrode, into the GI tract or the GI wall of a subject, from the exterior of the subject. The method for inserting the device in the GI wall includes inserting the needle until its end is positioned in the thickness of the GI wall, and inserting the device through an interior bore of the needle, such that engaging means of the device extends beyond the interior bore of the needle into the thickness of the wall. The needle is then removed, and the device is retracted until the engaging means engages the thickness of the wall.
US Patent Application Publication 2005/0251219 to Evans, which is incorporated herein by reference, describes endoscopic apparatus and methods for placement of electrodes in the gastric wall. The apparatus has one or more electrodes disposed on an elongated body having a pointed first end and a bolster disposed on a second end. When placed within the GI tract, the first end of the apparatus extends through the gastric and abdominal walls, extending outside of the patient's body with the bolster in contact against the inner lining of the gastric wall to retain the apparatus. Exposed electrodes contact the gastric smooth muscle. Insulated wires in electrical connection with-the electrodes run the length of the apparatus body. Once the apparatus is placed, the first end of the apparatus body is removed to expose the wires, allowing electrical connection to an external electrical signal generator to provide electrical stimulus.
US Patent Application Publication 2005/0192615 to Torre et al., which is incorporated herein by reference, describes a space-occupying device for deployment within a patient's stomach and methods of deploying and removing the device. The device includes an expandable member and fasteners, such as sutures, that extend to least partially through the patient's stomach wall, and that anchor the device with the patient's stomach. The device can be deployed and/or removed through transesophageal approaches and/or through a combination of transesophageal and transabdominal approaches.
US Patent Application Publication 2005/0143784 to Imran, which is incorporated herein by reference, describes techniques for anchoring a device to a stomach. The anchor of the device is constructed to resist pull out forces.
U.S. Pat. No. 6,535,764 to Imran et al., which is incorporated herein by reference, describes techniques for diagnosing and treating gastric disorders. A functional device resides within the patient's stomach and is secured to the stomach wall by an attachment device. In an embodiment, the device comprises an anchor which comprises a screw connector, which includes an electrode.
U.S. Pat. No. 6,606,523 to Jenkins, which is incorporated herein by reference, describes apparatus for stimulating neuromuscular tissue of the gastrointestinal tract, and methods for installing the apparatus to the surface of the neuromuscular tissue. A pair of electrodes are supported by an electrode attachment member having a distal surface configured for attachment to the surface of the neuromuscular tissue. The electrodes are supported adjacent the distal surface to provide an interface between the electrodes and the surface of the neuromuscular tissue. The electrode attachment member may be flexible to pass through a laparoscopic surgical access opening in a compacted form and then returned to an uncompacted form for attachment to the surface of the neuromuscular tissue by the use of staples or sutures. In an embodiment, an electrode assembly is provided with a substantially helical or corkscrew-type attachment member protruding from a distal surface of a patch. The helical attachment member may also serve as an electrode for stimulating the neuromuscular tissue.
U.S. Pat. No. 6,041,258 to Cigaina et al., which is incorporated herein by reference, describes a handle for an implant device used in laparoscopic surgery. The implant device is used for electrostimulation and/or electrical monitoring of endo-abdominal tissue or viscera. The implant device has an elongated body equipped with devices to secure it to the tissue to be treated and two or more electric poles that are electrically connected to an electric connection terminal for connection to a power source, means to penetrate the tissue to be treated, and quick-release connecting devices to separate the penetration device from the elongated body. The handle, which is an elongated body, is attached to the proximal end of the implant device or other medical device and has a grasping means at its opposite end for manipulation with laparoscopic forceps.
US Patent Application Publication 2003/0195600 to Tronnes et al., which is incorporated herein by reference, describes an implantable intramuscular lead system, such as for use as a gastric lead, and method of use in which electrodes along the lead are imbedded in tissue. First and second anchors are mounted on an elongate lead. At least the second anchor is movable along the length of the lead relative to the first anchor to capture the tissue between the anchors so that the lead is retained in position. The system facilitates implantation of the lead in tissue, and is described as being particularly suited for minimally invasive implantation, such as laparoscopically.
US Patent Application Publication 2005/0209653 to Herbert et al., which is incorporated herein by reference, describes an intra-luminal device for gastrointestinal electrical stimulation that is self-powered and self-contained within a capsule-like housing, and is capable of non-surgical implantation within the patient. The device includes an implantable pulse generator and one or more electrodes mounted within a common device housing. The device housing is capable of endoscopic introduction to a desired location within the gastrointestinal tract, such as the stomach, via the esophagus. In an embodiment, a stimulation device is secured within the gastrointestinal tract with a fixation mechanism using a vacuum cavity and pin to secure tissue.
U.S. Pat. No. 6,952,613 to Swoyer et al., which is incorporated herein by reference, describes active fixation, gastrointestinal leads adapted to be implanted within the body at a site of the GI tract for performing electrical stimulation and sensing. Described active fixation mechanisms include one or more of hooks, and helixes extending from stops, e.g. plates, of an electrode head and functioning as stimulation/sense electrodes in unipolar and bipolar configurations or simply as fixation mechanisms.
US Patent Application Publication 2002/0103424 to Swoyer et al., which is incorporated herein by reference, describes a GI tract stimulator and/or monitor implantable medical device (IMD) comprising a housing enclosing electrical stimulation and/or monitoring circuitry and a power source and an elongated flexible member extending from the housing to an active fixation mechanism adapted to be fixed into the GI tract wall is disclosed. After fixation is effected, the elongated flexible member bends into a preformed shape that presses the housing against the mucosa so that forces that would tend to dislodge the fixation mechanism are minimized. The IMD is fitted into an esophageal catheter lumen with the fixation mechanism aimed toward the catheter distal end opening whereby the bend in the flexible member is straightened. The catheter body is inserted through the esophagus into the GI tract cavity to direct the catheter distal end to the site of implantation and fix the fixation mechanism to the GI tract wall. The IMD is ejected from the lumen, and the flexible member assumes its bent configuration and lodges the hermetically sealed housing against the mucosa. A first stimulation/sense electrode is preferably an exposed conductive portion of the housing that is aligned with the bend of the flexible member so that it is pressed against the mucosa. A second stimulation/sense electrode is located at the fixation site.
US Patent Application Publication 2005/0055038 to Kelleher et al., which is incorporated herein by reference, describes a device and method for selectively engaging or penetrating a layer of a luminal organ wall where the luminal organ wall has a plurality of layers including an outermost layer and an innermost layer adjacent to the lumen of the organ. The device and method select one of the plurality of layers of the organ wall other than the innermost layer and deploy from within the lumen of the organ a tissue device through the innermost layer to a specific depth to engage or penetrate the selected one of the plurality of layers. The device and method may be employed to create luminal pouches or restrictive outlets. In a stomach organ, the device and methods may be employed to treat obesity by forming a gastric pouch with or without a restrictive outlet. In an embodiment, a securement device comprises a hollow needle which passes through a stomach wall into a safety gap between the outer surface of the wall and the liver, and which deploys a thread having a T-anchor on its end. In another embodiment, a restrictive outlet to a gastric pouch is created using a mucosal bunching device which is generally egg shaped, and has (a) a distal anvil, (b) an interior space into which mucosa is sucked using suction applied through vacuum ports, (c) a radial array of staples, and a (d) staple pusher 546. By deploying the device into the outlet of a gastric pouch and applying suction through the ports, the mucosa is sucked into the stapling space, and the staples are then pushed through the mucosa and formed against the anvil.
U.S. Pat. No. 6,363,937 to Hovda et al., which is incorporated herein by reference, describes techniques for selectively applying electrical energy to a target location within the gastrointestinal tract, such as the lower esophageal sphincter (LES). In an embodiment, the electrosurgical instrument comprises a catheter designed for advancement through the patient's mouth, down the esophagus into the region of the lower sphincter. In this embodiment, the catheter may optionally include an endoscope, or the system may include a separate endoscope.
PCT Publication WO 05/037152 to Stack et al., which is incorporated herein by reference, describes techniques for retaining a medical implant within a body cavity.
PCT Publication WO 02/089655 to Imran et al., which is incorporated herein by reference, describes techniques for diagnosing and treating gastric disorders. A submucosal gastric implant device is placed within the submucosal layer of a patient's stomach wall. The device in one embodiment provides electrical stimulation of the stomach wall and may use multiple electrode pairs for sequential stimulation. The device may also have other functional aspects such as a sensor for sensing various parameters of the stomach or stomach environment, or a therapeutic delivery device.
PCT Publication WO 05/041749 to Imran, which is incorporated herein by reference, describes a fixation device for holding stimulating electrodes in electrical contact with the wall of a portion of the gastrointestinal tract. In one embodiment, the fixation device includes an expandable member that fixes the electrodes in electrical contact with the gastrointestinal tract wall. Also described is an implantable device and method for controlling the opening and/or closing of the pylorus. In particular, a device and method is described for stimulating the duodenum to control the closing/and or opening of the pylorus. Finally, a method is described for treating obesity by controlling the pylorus to retain food in the stomach for a desired period of time, among other things to provide a feeling of satiety and/or to reduce hunger. One aspect includes controlling the pylorus's contraction by electrical stimulation of the duodenum.
US Patent Application Publication 2004/0158138 to Kilcoyne et al., which is incorporated herein by reference, describes an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed, including a method for attaching a device to a tissue surface inside of a patient. The method comprises providing a device having a housing, a concavity on the housing, and a pin which is axially movable from a retracted position within the housing to an extended position which extends at least part way across the concavity. The device is carried on an introduction instrument into the body, and positioned at an attachment site, such that the concavity is adjacent the tissue surface at the attachment site. Tissue is drawn into the concavity, and the pin is advanced through the tissue to retain the device at the attachment site.
US Patent Application Publication 2005/0203500 to Saadat, which is incorporated herein by reference, describes techniques for mapping out endoluminal gastrointestinal surgery, including endoluminal gastric reduction. Mapping is achieved by locally marking the interior of the gastrointestinal lumen at specified locations.
US Patent Application Publication 2005/0075654 to Kelleher, which is incorporated herein by reference, describes techniques for soft tissue securement, and, in particular, tissue anchoring elements and deployment thereof. Such tissue anchoring elements may comprise a linkage element and an array of spreading elements. Endoscopic devices and methods are disclosed for deploying multiple anchoring elements to multiple sites and manipulating at least some of the associated linkage elements to approximate selected sites. Applications of such endoscopic devices and methods may include endoluminal therapy such as gastroplasty, which may be used for the treatment of obesity and gastroesophageal disease. Such devices and methods may also include the attachment of a foreign body to a tissue mass. Further aspects of the invention include devices and methods for the modification of mechanical properties of the anchoring sites so as to decrease the likelihood that anchoring elements will pull out. Such modification may include irritating or injuring the tissue within the anchoring sites, thereby causing a healing or scarification response, or may alternatively include deploying a solidifying agent within the anchoring sites.
US Patent Application Publication 2004/0193184 to Laufer et al., which is incorporated herein by reference, describes techniques for reconfiguring a tissue within a hollow body organ using an entirely endoscopic approach in order to effectively reduce flow of fluid contents into a second hollow body organ in fluid communication with the first.
U.S. Pat. No. 5,423,872 to Cigaina, which is incorporated herein by reference, describes a method for treating obesity and syndromes related to motor disorders of the stomach of a patient. The methods consists of artificially altering, by means of sequential electrical pulses and for preset periods of time, the natural gastric motility of the patient to prevent emptying or to slow down gastric transit. The '872 patent also describes a device including an electrical stimulator which is appropriately located subcutaneously in the abdominal wall, is anchored to the fascia of the musculus rectus abdominis, and is connected to the distal gastric antrum by means of an electrocatheter the terminal portion thereof of which is provided with metallic micro-barbs, for example two, which are angled so as to allow application of the tip of the catheter and prevent its extraction.
U.S. Pat. No. 5,837,006 to Ocel et al., which is incorporated herein by reference, describes an endocardial, active fixation, screw-in lead of the type having a fixation helix adapted to be rotated in a first, advancement direction out of an electrode head chamber and into cardiac tissue by rotation of a lead connector end and attached lead conductor with respect to an insulating sheath in the first direction and retracted into the chamber by rotation of the lead connector in the opposite, retraction direction. The lead includes a retraction stop mechanism for preventing over rotation of the helix in the retraction direction. The rotational motion of the lead conductor is transmitted to the helix by a connecting assembly and is translated into axial advancement and retraction of the helix by a guide cooperating with the helix turns. A retraction stop mechanism stops rotation of the helix in the retraction direction upon full retraction of the helix into the chamber and allows rotation of helix in the advancement direction. The retraction stop mechanism includes a fixed stop formed of a plurality of fixed cam and axial stop surfaces surrounding a proximal end bore of the chamber through which the lead conductor passes and a movable stop formed in the connecting mechanism of a like plurality of rotatable cam and axial stop surfaces aligned to face the fixed cam and axial stop surfaces adapted to engage in a locked relation of the stop surfaces upon full retraction of the fixation device into the chamber.
The following patents and patent application publications, all of which are incorporated herein by reference, may be of interest:    U.S. Pat. No. 6,918,871 to Schulze    U.S. Pat. No. 5,247,938 to Silverstein et al.    U.S. Pat. No. 6,754,536 to Swoyer et al.    U.S. Pat. No. 6,876,885 to Swoyer et al.    U.S. Pat. No. 6,745,079 to King    U.S. Pat. No. 6,852,110 to Roy et al.    U.S. Pat. No. 3,737,579 to Bolduc    U.S. Pat. No. 4,010,758 to Rockland et al.    U.S. Pat. No. 4,235,246 to Weiss    U.S. Pat. No. 4,452,254 to Goldberg et al.    U.S. Pat. No. 4,000,745 to Goldberg et al.    U.S. Pat. No. 4,357,946 to Dutcher et al.    U.S. Pat. No. 4,313,448 to Stokes    U.S. Pat. No. 4,177,818 to De Pedro    U.S. Pat. No. 6,510,332 to Greenstein    U.S. Pat. No. 6,321,124 to Cigaina    U.S. Pat. No. 6,477,423 to Jenkins    US Patent Application Publication 2005/0183732 to Edwards    US Patent Application Publication 2005/0107829 to Edwards et al.    US Patent Application Publication 2003/0220678 to Tronnes et al.    US Patent Application Publication 2004/0088023 to Imran et al.    US Patent Application Publication 2005/0065505 to Ryan    PCT Publication WO 04/069330 to Knudson et al.    PCT Publication WO 04/096337 to De Winter    PCT Publication WO 03/020365 to Swoyer et al.    European Patent Application Publication EP 1 447 052 A2    Japanese Patent Application Publication JP 2003/319945 to Schulze et al.
Swain et al., in “An endoscopically deliverable tissue-transfixing device for securing biosensors in the gastrointestinal tract”, Gastrointestinal Endoscopy 40(6): 730-734 (1994), which is incorporated herein by reference, describe an attachment mechanism that uses suction to draw a fold of the stomach wall together, and inserts a preformed, Nylon, H-shaped tag through the fold of the stomach wall.
Wagh M S et al., in “Endoscopic transgastric abdominal exploration and organ resection: initial experience in a porcine model,” Clin Gastroenterol Hepatol 3(9):892-6 (2005), which is incorporated herein by reference, describe a study which assessed the ability to systematically identify abdominopelvic organs using an endoscope via a per-oral transgastric route. A gastroscope was used to place a sterile over-tube into the esophagus of pigs. After antibacterial lavage, the gastric wall was incised, and a sterile dual-channel endoscope was advanced into the peritoneal cavity. Endoscopic abdominal exploration was performed, and the gastric incision was closed with endoclips.